BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALAXPRESS LIQUID

    MDR report key: 5471490 · Received March 1, 2016

    Report

    Report Number
    9610902-2016-00006
    Event Type
    Injury
    Date Received
    March 1, 2016
    Date of Event
    February 4, 2016
    Report Date
    February 11, 2016
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EBI
    PMA / PMN Number
    K902115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION# E2012008, HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER GMBH (THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. NARRATIVE: DEVICE HAS NOT BEEN RETURNED BY CUSTOMER, AND THE PATIENT IS NON-COMPLIANT. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    PATIENT CLAIMS TO HAVE ADVERSE REACTION TO TEMPORARY DENTURE MANUFACTURED WITH PALAXPRESS LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126984 PALAXPRESS LIQUID RESIN, DENTURE, RELINING, REPAIRING, REBASING EBI HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other